A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma

A Randomized, Open-Label, Multicenter, Phase 2/3 Clinical Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1)

Inclusion Criteria: * 18 years and older * ECOG 0-1 * Life expectancy ≥ 6 months * Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component * No prior systemic therapy for LA/mUC * At least one measurable non-cerebral lesion according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Locally advanced disease that is resectable or suitable for local therapy with curative intent. * Tumors containing any small cell or neuroendocrine differentiation * Ongoing sensory or motor neuropathy Grade 2 or higher. * Radiographic findings consistent with a high risk of bleeding * History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose.